Simultaneous Quantitative Resolution and Validation of Binary Mixture in a Pharmaceutical Dosage Form by Using a Spectrophotometric Signal Processing Technique

Abstract

Objective: In this context, a rapid and powerful signal processing approach, a ratio-derivative spectrophotometry (RDS) method were developed for the simultaneous determination of irbesartan (IRB) and hydrochlorothiazide (HCT) in a tablet. Material and Method: The RDS method was applied to the UV spectra of the IRB and HCT. The calibration equations were obtained by measuring amplitudes at 236.3 nm for the IRB determination and at 260.0 nm for the HCT determination, respectively. The proposed method was validated by using the recovery studies, intra-day and inter-day assays and standard addition technique. Result and Discussion: This study aims to apply a rapid and powerful signal processing method to the simultaneous quantification of IRB and HCT in their synthetic mixtures and tablets. As can be seen, the UV spectra of two drugs overlapped strongly in same spectral region. Direct conventional absorbance measurements do not give expected results for the IRB-HCT tablet analysis mainly due to the spectral interference. However, in order to reach a reasonable spectral analysis outcome, we focused mainly on the application of the ratio-derivative spectra treatment to the quantitative resolution of IRB-HCT mixtures without having to a separation procedure.